TS1A: INTRODUCTION TO BIOPROCESSING

MONDAY, AUGUST 12 AND TUESDAY, AUGUST 13
DAY ONE: 1:00 – 5:00 PM | DAY TWO: 8:00 AM – 5:00 PM

Cambridge

INSTRUCTORS:

Sheila G. Magil, PhD, Managing Director, Industry Specialized Services, BDO

Frank J. Riske, PhD, Managing Director, Industry Specialized Services, BDO

CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at scaling up for commercial production. The seminar also explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles of analytical methods at all stages of development as well as formulation and stability assessments in developing and gaining approval for a biopharmaceutical are also examined. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.

TOPICS TO BE DISCUSSED:

An Introduction to Biopharmaceuticals and Bioprocessing

Analytical Methods for the Characterization and Release of Biotherapeutics

• Structure-function
• Bioassay
• Higher-order structure
• Phase-appropriate methods

Quality Systems

• Overview
• Quality by Design (QbD)
• Phase-appropriate quality systems

The Science and Technologies of Bioprocess Unit Operations

Cell Line and Upstream Development

• Expression system selection and development
• Cell banking: Master and working cell bank generation and testing
• Cell culture and fermentation development
• Continuous feed/perfusion/fed batch
• Single use

Recovery and Downstream Development

• Affinity capture
• Platform processes
• Purification development strategies
• Polishing and final processing
• Viral clearance validation

Drug Product Development

• Liquid, lyophilized and other forms
• Formulation development
• Device and packaging considerations
• Combination products

Scaling Up Drug Substance

• Considerations in scaling up
• Engineering and first cGMP runs
• Facility considerations
• Tech transfer

Comparability during Scale-Up and after Process Changes

Ready for Late-Stage Development

• Process qualification
• Facility concerns
• Equipment qualification

Ready for Commercial

• What is needed
• Supply chain considerations
• BLAs/NDAs

INSTRUCTOR BIOGRAPHIES:

Sheila G. Magil, PhD, Managing Director, Industry Specialized Services, BDO

Sheila Magil has over 20 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a PhD in Biochemistry from the University of Minnesota.

Frank J. Riske, PhD, Managing Director, Industry Specialized Services, BDO

Frank J Riske has over 25 years of experience in the biopharmaceutical industry. Prior to joining BioProcess Technology Consultants and BDO, Dr. Riske was Senior Director in the Late Phase Process Development Group at Genzyme, a Sanofi company. Before Genzyme, Dr. Riske held positions at Epic Therapeutics, Repligen and Hoffmann-LaRoche. Dr. Riske has extensive experience in the development of downstream processes for cytokines, proteins and virus from plasma, E coli, Pichia and mammalian systems and in the development and manufacture of novel drug delivery systems. Dr. Riske received his B.S. in Biology from Fairfield University, PhD in Biochemistry and Microbiology from Rutgers University and completed a post-doctoral position at Hoffmann-LaRoche.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.